# K260061: BioHorizons CEREC Compatible Ti-Bases

- Pathway: 510(k) (Traditional)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Jun 26, 2026 after 169 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K960026 (1996). 297 ancestors in all.
No later device cites it as a predicate yet.
0 of 298 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240187: Tapered Pro Conical Implant System, BioHorizons Implant Systems, Inc. (2024) Summary page 5.

## Indications for use
BioHorizons Chairside Ti-Bases connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations. BioHorizons 3.0 Chairside Ti-Bases are limited for use as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors when used with 3.4mm diameter implants. All digitally designed abutments and/or copings for use with Chairside Ti-Bases are to be designed using Sirona CEREC® Software and manufactured using a Sirona CEREC® MC XL milling unit. Conical CEREC Compatible Ti Bases connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally designed abutments and/or copings for use with Conical CEREC Compatible Ti Bases are to be designed using Sirona CEREC® Software and manufactured using a Sirona CEREC® MC XL milling unit.

Source page: https://510kreport.com/device/K260061
Methodology: https://510kreport.com/methodology